Phase 3
Completed N=274
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT00853099 ↗Enrolled (actual)
274
Serious AEs
23.6%
Results posted
Nov 2012
Primary outcomePrimary: Percentage of Participants With Clinical Remission at 8 Weeks — 11.5; 13.8; 10.0 percentage of participants
Summary
The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Remission at 8 Weeks |
11.5; 13.8; 10.0 | — |
| PRIMARY Percentage of Participants With Clinical Remission at 52 Weeks |
7.3; 26.4; 20.0 | — |
| SECONDARY Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks |
11.5; 13.8; 10.0; 8.3; 17.2; 17.8 | — |
| SECONDARY Percentage of Participants With a Clinical Response |
35.4; 42.5; 50.0; 20.8; 33.3; 37.8 | — |
| SECONDARY Percentage of Participants With Mucosal Healing |
30.2; 39.1; 44.4; 21.9; 27.6; 31.1 | — |
| SECONDARY Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) |
67.7; 80.5; 71.1; 28.1; 40.2; 43.3 | — |
| SECONDARY Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) |
44.8; 47.1; 61.1; 28.1; 36.8; 37.8 | — |
| SECONDARY Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) |
32.3; 34.5; 40.0; 20.8; 33.3; 31.1 | — |
| SECONDARY Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders |
39.6; 48.3; 42.2; 21.9; 33.3; 28.9 | — |
| SECONDARY Number of Participants With Adverse Events up to Week 8 |
45; 49; 40; 10; 14; 12 | — |
| SECONDARY Number of Participants With Adverse Events up to Week 52 |
67; 68; 75; 17; 23; 32 | — |
| SECONDARY Number of Participants With Adverse Events During the Adalimumab Treatment Period |
261; 142; 90; 37 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
- Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy subscore of 2-3 during the Screening Period, despite concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
- Stable oral corticosteroid dose (prednisolone dose of ≥ 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of 5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or
- At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline, with a dose of azathioprine ≥ 50 mg/day or 6-MP ≥ 30 mg/day, or a dose that was the highest tolerated by the patient.
Exclusion Criteria
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.
- Patients with disease limited to the rectum.
- Indeterminate colitis and/or Crohn's disease.
- Received any biological therapy (including infliximab) in the past.
- History of tuberculosis or malignancy.
- Pregnant women.
- Patients with positive C. difficile stool assay at Screening.
- Current diagnosis of fulminant colitis and/or toxic megacolon.
Data sourced from ClinicalTrials.gov (NCT00853099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.